Extralabel use of drugs in small ruminants can be a confusing issue, highlighted by complicated regulations, an openness for interpretation, and in individual animal's intended use. In this session, I will attempt to give an overview of the regulations regarding extralabel drug use in small ruminants, some guidance in decision-making, and resources I have found useful. This will only focus on sheep and goats. It is very important to note that the information provided is time-sensitive, subject to change at any time, and is based on my own interpretation of the regulations and should not be used as the final word in extralabel drug use decision-making.
There are a variety of agencies, acts, and research groups involved in the guidance of extralabel drug use in food animals, including FDA, USDA (biologics), EPA (pesticides), National Research Support Project #7 (NSRP-7), Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, Minor Use and Minor Species (MUMS) Animal Health Act of 2004.
Some definitions per the FDA:
The FDA maintains a list of prohibited drugs for use in food animals. For these drugs, extralabel use in food animals is not allowed under any circumstances. The list currently includes: chloramphenicol, nitroimidazoles (including dimetridazole, metronidazole and ipronidazole), sulfonamides in adult dairy cattle (>20 months of age, except for on-label use of sulfadimethoxine), clenbuterol, dipyrone, fluoroquinolones, glycopeptides (vancomycin), nitrofurans (topical included in prohibition), phenylbutazone in adult dairy cattle, genetian violet.
• Extralabel : use of any approved drug (prescription or over the counter) in a manner that is not in accordance with the approved label or the package insert. [This may include use in a different species, route of administration, dosage or dosing frequency.]
• Minor species: species other than cattle, horses, swine, chickens, turkeys, dogs and cats (sheep were a major species until 2000)
• Drug: any compound for which the diagnosis, cure, treatment, mitigation, or prevention of a disease is claimed
• Withdrawal time: the time at which 99% of animals would be expected to reach the tolerance level for drug residue